The Recall Desk

Manufacturer

Medtronic Xomed, Inc.

26 recalls in our database name Medtronic Xomed, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
6
Most recent
2025-09-03

Of the 26 recalls from Medtronic Xomed, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (23%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • ModerateFDA (Devices)·Z-2461-2025·2025-09-03

    Surgical driver systems recalled over out of the box driver wobble

    IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.

    Product
    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1623-2025·2025-04-30

    Medtronic NIM Vital Nerve Monitoring System Software Version Recall

    Medtronic is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased stimulus artifact that may require troubleshooting and could lead to procedure delay, extubation, and medical intervention.

    Product
    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3130-2024·2024-09-18

    Medtronic ENT Surgical Cutting Bur Distributed Past Expiration Date

    Medtronic Xomed recalled an ENT Ultra Round Steel Cutting Bur (Model REF 31313069) because it was distributed past its expiration date. This device was distributed internationally, including to Canada.

    Product
    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2409-2024·2024-07-31

    NIM Vital Nerve Monitoring Systems Recalled for False Negative Risk

    Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.

    Product
    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2024·2024-01-17

    NIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring

    Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes worldwide for noise, lead-off issues, high impedance, and loss of or intermittent nerve monitoring. The 80,569 affected units may fail to provide reliable nerve monitoring function.

    Product
    NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1521-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1520-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2022·2022-09-07

    Medtronic endotracheal tubes recalled for reported airway obstruction risk

    Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.

    Product
    NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1223-2022·2022-06-08

    Medtronic NIM Vital Console 4.0 Surgical Nerve Monitoring Device Software Anomaly Recall

    Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.

    Product
    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2022·2022-06-08

    Medical Device Patient Interface Recalled Due to Software Anomaly

    Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.

    Product
    NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2022·2022-04-27

    Medical device software defect causes incorrect rotation count in surgical handpiece

    Medtronic Xomed integrated power console software version 2.7.3.0 has a defect that causes the set number of rotations to mismatch the actual rotations in specific modes when used with M5 handpieces. No injuries have been reported.

    Product
    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0743-2022·2022-03-16

    Medtronic endotracheal tubes recalled due to manufacturing nonconformity

    Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.

    Product
    NIM TRIVANTAGE EMG Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2022·2021-10-27

    Medtronic Surgical Blades Recalled Due to Tip Breaks and Vibration

    Medtronic is recalling surgical blades used in ENT procedures due to increasing complaints of tip breaks and vibration. Approximately 274,991 devices distributed worldwide are affected.

    Product
    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2022·2021-10-27

    Medtronic surgical blades recalled for tip breaks and vibration

    Medtronic recalls 274,991 sterile surgical blades due to complaints of tip breaks and vibration during use. The blades are components of surgical systems used in brain and ENT procedures.

    Product
    Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2022·2021-10-27

    Medtronic Sterile Surgical Blades Recalled for Tip Breaks and Vibration

    Medtronic Xomed, Inc. is recalling 274,991 sterile single-use surgical blades used in ENT surgical procedures due to increased complaints of tip breaks and vibration during use.

    Product
    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2020·2020-07-29

    Medtronic Xomed IPC Software Upgrade Recalled for Speed Control Issue

    Medtronic Xomed is recalling IPC software upgrade v 2.7.3.0 because the M5 Microdebrider may rotate faster than the set value.

    Product
    Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2020·2020-01-01

    Medtronic Lamicel Cervical Dilators Recalled for Sterilization Defect

    Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did not meet the required Sterility Assurance Level.

    Product
    Lamicel 20PK 3MM INTL Cervical dilator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0901-2017·2017-01-04

    Medtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes because wire in the tubing can become exposed, posing potential harm to intubated patients.

    Product
    NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2013·2013-10-02

    Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error

    Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.

    Product
    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2013·2013-08-21

    Medtronic Xomed Recalls ENT Surgical Instrument Trays for Labeling Defects

    Medtronic Xomed is recalling 3,562 ENT surgical instrument trays to replace them with units featuring improved 'PREVACUUM ONLY' labeling.

    Product
    Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1420-2013·2013-06-12

    Medtronic Recalls NIM TriVantage EMG Endotracheal Tubes Due to Cuff Leakage

    Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes because the cuff may leak during surgery, requiring re-inflation or replacement to maintain patient ventilation.

    Product
    REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electrom
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2344-2012·2012-09-19

    Medtronic Recalls NIM 3.0 Patient Interfaces Due to Signal Loss

    Medtronic Xomed is recalling seven NIM 3.0 Patient Interfaces because they may fail to detect electrode signal loss, potentially delaying surgical procedures.

    Product
    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2012·2012-09-19

    Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss

    Medtronic Xomed is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss from the electrode.

    Product
    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 US
    Category
    Medical Device
    Distribution
    Distributed nationwide